Military University Hospital
Prague, 16902, Czechia
Location status: Recruiting
NCT Number: NCT05929365
It is known that the development of colorectal adenoma is dependent on the appearance of somatic mutations in protooncogenes and tumor suppressor genes. Based on our previous mutation analyses of 120 patients with high-risk adenoma removed by enbloc resection with subsequent colonoscopy after 1 year, there is a correlation between mutation in exon 7 of the TP53 gene and risk of early metachronous lesions development. The results also indicate that mutation phenotype (mutation profile and burden) of all lesions detected on index colonoscopy can determine risk of metachronous lesions. As not all synchronous lesions were analyzed and the surveillance colonoscopy interval was less than 3 years, this assumption could not be confirmed. In this study it is planned to perform mutation analysis of all synchronous lesions in 200 patients and correlate the data with appearance of metachronous lesions after 1, 3 and 5 years. Moreover, the mutation profile of all metachronous lesions developed during the 5 years of surveillance will be determinated and compared with mutation profile of index lesions from the same localization to verify their common biological origin. This all could help personalize the surveillance program in terms of reduction of the burden on the patient and endoscopic workplaces and risk of developing colorectal cancer in a particular patient.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Prague, 16902, Czechia
Location status: Recruiting
The aim of this prospective study is to identify patients with recurrent colorectal lesions risk and try to design an optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype. The partial goals are: 1. Determination of the mutation profile and mutation burden in 200 patients based on examination of all their index and synchronous lesions found during index colonoscopy using an established PCR/DCE-based heteroduplex method. 2. Clinical and histopathological evaluation and mutational profiling of all metachronous lesions found during five-year surveillance period. 3. Correlation of clinical and histopathological parameters with mutational phenotype of patient. 4. Correlation of patient's mutational phenotype with an occurrence of metachronous lesion/s during surveillance period. 5. Comparison of the mutation profile of lesions from the index period withthe mutation profile of metachronous lesions. 6. Analysis of the similarity of the mutation profile of lesions found in the same / close areas of the colorectum.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
determine the mutation profile of resected colorectal neoplasia
Other names: endoscopic resection
Time frame: 5 years
To identify patients with high risk of metachronous colorectal lesions and try to design and optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype.
Time frame: 5 years
Determination of the mutation profile and mutation burden in 200 patients based on examination of all their index and synchronous lesions found during index colonoscopy using an established PCR/DCE-based heteroduplex method.
Time frame: 5 years
Clinical and histopathological evaluation and mutational profiling of all metachronous lesions found during five-year surveillance period.
Time frame: 5 years
Correlation of clinical and histopathological parameters with mutational phenotype of patient.
Time frame: 5 years
Correlation of patient's mutational phenotype with an occurrence of metachronous lesion/s during surveillance period.
Time frame: 5 years
Analysis of the similarity of the mutation profile of lesions found in the same / close areas of the colorectum.
Contact information is provided by the study sponsor or research team.
Military University Hospital, Prague
Other
Development and Clinical Utility of a New Method to Identify Patients With Risk of Recurrent Colorectal Lesions and Personalization of Their Surveillance Based on Mutation Burden and Clinical-pathological Phenotype
Acronym: MTG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06364371
Disease Attributes, Disease Progression
Guangzhou, Guangdong, China
View Trial DetailsNCT06391892
Circulating Tumor Cell, Digestive System Diseases
Linz, Upper Austria, Austria
View Trial DetailsNCT06202404
Metastasis, Neoplasm Metastasis
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT04185779
Colonic Diseases, Colorectal Adenoma
South Shields, Tyne and Wear, United Kingdom
View Trial Details